Lead Process/Project Engineer (Pharma/Biotech)

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; On-site; SGD 150,000 - 230,000; Full time

Job summary

NUSANTARA PRIME CONSULTING PTE. LTD. in Tuas, Singapore, seeks a senior Process Engineer to own full lifecycle equipment packages including design, FAT/SAT, IQ/OQ/PQ, and commissioning activities on site.

You will lead a team of engineers across upstream, downstream and central services, ensuring on-time delivery within budget and quality constraints. The role requires 10–15 years of process engineering experience in biologics with strong CGMP understanding and hands-on design at multiple

Qualifications

• Advanced Degree in Chemical Engineering, Chemistry or equivalent.
• Process Engineer with at least 10-15 years of experience.
• Able to manage a team of Process Engineers (5 to 10 engineers).
• In Biologics industry with understanding of cGMP requirements.
• Should have Design experience at various stages of project (Base, Detailed design).
• Preferably handling the Autoclave, Glove box, CIP Skid during project phase.
• Able to support Installation, Commissioning & Qualification activity at site.
• Any other task given related to Process.

Responsibilities

• Good experience in upstream, downstream and Central services process operation and has experience in equipment design for process equipment.
• Oversee a team of Process Engineers (5 to 10 engineers)
• Responsible to ensure on-time delivery of packages including basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ.
• Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations.
• Engage with project teams and motivate Process Engineers to deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements.
• Coordinates with different functions like manufacturing, project engineering team, validation and quality for implementation of changes associated with the project.
• Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints.
• Any other task as assigned by Supervisor/Manager.

Skills

Process Engineering

Team Leadership

cGMP

Project Engineering

Equipment Design

Installation & Commissioning

Education

Advanced Degree in Chemical Engineering

Job description

The candidate is responsible for Equipment Package Ownership (full lifecycle – Engineering Design, Build, Testing (FAT), Installation and Commissioning), including experience in commissioning and qualification of process equipment.

Responsibilities:

• Good experience in upstream, downstream and Central services process operation and has experience in equipment design for process equipment.

• Oversee a team of Process Engineers (5 to 10 engineers)

• Responsible to ensure on-time delivery of packages including basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ.

• Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations.

• Engage with project teams and motivate Process Engineers to deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements.

• Coordinates with different functions like manufacturing, project engineering team, validation and quality for implementation of changes associated with the project.

• Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints.

• Any other task as assigned by Supervisor/Manager.

About You:

• Advanced Degree in Chemical Engineering, Chemistry or equivalent.

• Process Engineer with at least 10-15 years of experience

• Able to manage a team of Process Engineers (5 to 10 engineers)

• In Biologics industry with understanding of cGMP requirements

• Should have Design experience at various stages of project (Base, Detailed design)

• Preferably handling the Autoclave, Glove box, CIP Skid during project phase

• Able to support Installation, Commissioning & Qualification activity at site.

• Any other task given related to Process.
  

  Location: Tuas